Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243646
Status:
TERMINATED
Last Update Posted:
2016-04-14
First Post:
2005-10-20
Brief Title:
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy A Prospective Randomized Trial
Sponsor:
Schiffler Cancer Center
Organization:
Schiffler Cancer Center
Study Overview
Official Title:
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy A Prospective Randomized Trial
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients
Detailed Description:
In calender year 2005 220 000 men will be diagnosed with prostate cancer and approximately 30000 will subsequently die of metastatic disease Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community However patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy favorable long-term biochemical outcomes have been reported for patients with low intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities 12
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy 65-70 Gyresults in improvement in disease-free and overall survival in patients with locally advanced prostate cancer 34
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy favorable long-term biochemical outcomes have been reported for patients with low intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities 12
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy 65-70 Gyresults in improvement in disease-free and overall survival in patients with locally advanced prostate cancer 34
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None